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Innovacon, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000057104

Devices
262
Registrations
EUDAMED
FDA recalls
1

What Innovacon, Inc. makes

Innovacon, Inc. manufactures in vitro diagnostic devices, including the INNOVACON HCG UKTRA TEST DEVICE, INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE, and INNOVACON SPECTRUM II TEST CARD.

The company's devices are classified as Class II and listed in the FDA 510(k) registry. Innovacon, Inc. is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue262

Newest first, rows 251-262 of 262

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  • SureStep CE Ref DED-A114

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • SureStep CE Ref DOA-1105-111

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • InstAlert Ref FHC-U202

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • SureStep CE Ref DOA-165-021

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • SureStep CE Ref DOA-1105-031

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • SureStep CE Ref DKE-101

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • SureStep Ref DOA-174-691

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • SureStep CE Ref DOA-164-251

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • SureStep CE Ref DOA-1124-031

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • Innovacon Hcg Uktra Test Device Ref K062361 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Innovacon Flipcard Fecal Occult Blood Test Device Ref K063673

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Innovacon Spectrum Ii Test Card Ref K061718

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 251-262 of 262

Showing 251-262 of 262

Company details

EUDAMED SRN
US-MF-000057104
EUDAMED status
Active
EUDAMED registered name
Innovacon, Inc.
EUDAMED abbreviated name
Innovacon
Registered address
9942, Mesa Rim Road, 92121, San Diego, United States
PRRC contact
Irene Yasuda(public in EUDAMED)

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by Innovacon, Inc., initiated on 2007-10-01. By recorded status: 1 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2007

    • 1 Oct 2007 Z-1118-2008 Unclassified (pre-2012) Terminated Incorrect results: The Sure-Vue Serum/Urine hCG-STAT test, when interpreted at extended read times, may exhibit sensitivity to patient samples containing hCG at levels well below the cut-off, potentially resulting in a false positive interpretation by the user. Distribution: Nationwide Submission number: K062361